HIP. Instrument User Guide Revision 1.1. Copyright 2015, Brainlab AG Germany. All rights reserved.

Transcription

1 HIP Instrument User Guide Revision 1.1 Copyright 2015, Brainlab AG Germany. All rights reserved.

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3 TABLE OF CONTENTS TABLE OF CONTENTS GENERAL INFORMATION...7 Contact Data and Legal Information...7 Contact Data...7 Legal Information...8 Symbols...9 Symbols Used in this Guide...9 Hardware Symbols...10 Intended Use...12 Hardware Handling...12 Training and Documentation...13 Training...13 Documentation...14 INSTRUMENTATION OVERVIEW...15 Instrument Handling...15 Safety Critical Information...15 Using Fixation Pins...16 Available Instruments...17 GENERAL INSTRUMENTATION...21 Disposable Reflective Marker Spheres...21 Overview...21 Using Marker Spheres...22 Disposable Schanz Screws...24 Overview...24 Instrument Calibration Matrix (Rev. 4) - ICM4 (41874)...25 ICM Features...25 POINTERS...27 Using Pointers...27 Handling Pointers...27 Maintaining Pointer Accuracy...28 Types of Pointers...29 Disposable Clip-on Remote Control (53153)...31 Instrument User Guide Rev. 1.1 Hip 3

4 TABLE OF CONTENTS Overview...31 Attaching the Disposable Clip-on Remote Control...32 Using the Disposable Clip-on Remote Control...34 After Use...35 Technical Specifications...36 Electromagnetic Compatibility and Emissions...38 Electromagnetic Immunity...39 RF Communications Equipment...41 Footswitch (USB) (18460)...42 Overview...42 HIP CALIPER...43 Hip Caliper (52876)...43 Using the Hip Caliper...43 REFERENCE ARRAYS, X-PRESS...45 Instrument Overview...45 Introduction...45 Reference Array, X-Press Kits...46 Bone Fixators, X-Press...47 Overview...47 Using Schanz Screws with Bone Fixators...48 Using the Bone Fixator 1-Pin, X-Press...50 Bone Fixator 2-Pin, Flip-Flop, X-Press (52429)...53 Attaching the Bone Fixator 2-Pin, Flip-Flop, X-Press...54 Reference Arrays, X-Press...56 Reference Array, X-Press Overview...56 Array Extension (52417)...57 Attaching and Detaching the Reference Array...60 Preparation for Registration...62 PINLESS FEMUR REFERENCE ARRAY...65 Instrument Overview...65 Introduction...65 Attaching the Base Plate and Reference Array...66 INSTRUMENT ADAPTERS...69 Using Adapters...69 Overview...69 Instrument Adapter, StarLock Interface (55080, 55085)...70 Overview...70 Attaching the StarLock...71 Adapter for Cup Inserter (41851) Instrument User Guide Rev. 1.1 Hip

5 TABLE OF CONTENTS Overview...72 Attaching the Adapter for Cup Inserter...73 Cup Reamer Adapter (41879)...75 Overview...75 Attaching the Cup Reamer Adapter...76 Femoral Broach Adapter DePuy (41852)...78 Overview...78 Attaching the Femoral Broach Adapter DePuy...79 SURGICAL INSTRUMENTS...81 Stem Position Verification Tools...81 Overview...81 Offset Cup Impactor Universal (52856)...83 Overview...83 Removing and Replacing the Impactor Nosepiece...85 Changing the Threaded Tip...86 Affixing and Locking the Implant on the Impactor...88 Steps Prior to Impaction...89 Releasing the Implant after Impaction...90 Straight Cup Impactor Universal (52858)...91 Overview...91 Assembling the Straight Cup Impactor...93 Adding and Removing the Impactor Nosepiece...95 Affixing and Locking the Implant on the Impactor (Symmetrical Nosepiece)...96 Affixing and Locking the Implant on the Impactor (Form Fit Nosepiece)...97 Steps Prior to Impaction...98 Releasing the Implant after Impaction Insert For Universal Cup Impactor (52855) Overview Drill Guide (41839) Overview Assembling the Drill Guide Navigation INDEX Instrument User Guide Rev. 1.1 Hip 5

6 TABLE OF CONTENTS 6 Instrument User Guide Rev. 1.1 Hip

7 GENERAL INFORMATION 1 GENERAL INFORMATION 1.1 Contact Data and Legal Information Contact Data Support If you cannot find information you need in this guide, or if you have questions or problems, contact Brainlab support: Region Telephone and Fax United States, Canada, Central and South America Tel: Fax: Brazil Tel: (0800) us.support@brainlab.com UK Tel: Spain Tel: France and French-speaking regions Tel: Africa, Asia, Australia, Europe Tel: Fax: support@brainlab.com Japan Tel: Fax: Expected Service Life Unless specifically stated otherwise, there is no defined service life for instruments. The end of service life depends on wear and damage during use. Repeated reprocessing has minimal effect on the service life time. Feedback Despite careful review, this manual may contain errors. Please contact us at igs.manuals@brainlab.com if you have suggestions as to how we can improve this manual. Manufacturer Brainlab AG Kapellenstr Feldkirchen Germany Instrument User Guide Rev. 1.1 Hip 7

8 Contact Data and Legal Information Legal Information Copyright This guide contains proprietary information protected by copyright. No part of this guide may be reproduced or translated without the express written permission of Brainlab. Trademarks Precimed is a registered trademark of Precimed. CE Label The CE label shows that the Brainlab product complies with the essential requirements of the Medical Device Directive (MDD). According to the MDD (Council Device Directive 93/42/EEC), the classification of the Brainlab product is defined in the corresponding Software User Guide. NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab. Disposal Instructions When a surgical instrument reaches the end of its functional life, clean the instrument of all biomaterial/biohazards and safely dispose of the instrument in accordance with applicable laws and regulations. Only dispose of electrical and electronic equipment in accordance with statutory regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) directive, visit: Sales in the US US federal law restricts this device to sale by or on the order of a physician. 8 Instrument User Guide Rev. 1.1 Hip

9 GENERAL INFORMATION 1.2 Symbols Symbols Used in this Guide Warnings Warnings are indicated by triangular warning symbols. They contain safety-critical information regarding possible injury, death or other serious consequences associated with equipment misuse. Cautions Cautions are indicated by circular caution symbols. They contain safety-critical information regarding possible problems with the device. Such problems include device malfunctions, device failure, damage to device or damage to property. Notes NOTE: Notes are formatted in italic type and indicate additional useful hints. Instrument User Guide Rev. 1.1 Hip 9

10 Symbols Hardware Symbols Symbols on Hardware Components Symbol Explanation Type B Applied Part according to IEC Type BF Applied Part according to IEC Caution Potential equalization point MR Safe MR Unsafe MR Conditional: The number shown on each label specifies the MR environment in which the device can be used with caution Do not reuse Non-Sterile Do not resterilize Sterilized with ethylene oxide Do not use if packaging is damaged Keep away from sunlight Keep dry Storage conditions for relative humidity non-condensing: The specified humidity range is shown on each label Storage conditions for air pressure: The specified air pressure range is shown on each label 10 Instrument User Guide Rev. 1.1 Hip

11 GENERAL INFORMATION Symbol Explanation Storage conditions for temperature: The specified temperature range is shown on each label Quantity of products in packaging Batch number Serial number Article number Use by month YYYY Date of manufacture Manufacturer Authorized representative in the European Community IPXY Ingress Protection according to IEC X = Protection against ingress of solid objects Y = Protection against ingress of liquid Direct current Acoustic power output of integrated ultrasound probes complies with FDA Track 3 and IEC On/off switch Standby switch to bring the device into standby mode Consult the operating instructions Attention! Consult accompanying documents Instrument User Guide Rev. 1.1 Hip 11

12 Intended Use 1.3 Intended Use Hardware Handling Place of Use The medical devices in this user guide are to be used in the operating room. Careful Hardware Handling Only trained medical personnel may operate system components and accessory instrumentation. System components and accessory instrumentation comprise precise mechanical parts. Handle them carefully. Plausibility Review Before patient treatment, review the plausibility of all information input to and output from the system. 12 Instrument User Guide Rev. 1.1 Hip

13 GENERAL INFORMATION 1.4 Training and Documentation Training Brainlab Training To ensure safe and appropriate use, before using the system all users should participate in a training program held by a Brainlab representative. Supervised Support Before using the system for surgical procedures where computer-aided navigation is considered critical, perform a sufficient number of complete procedures with a Brainlab representative present to provide guidance where necessary. Responsibility This system solely provides assistance to the surgeon and does not substitute or replace the surgeon s experience and/or responsibility during its use. Instrument User Guide Rev. 1.1 Hip 13

14 Training and Documentation Documentation Intended Audience This user guide is intended for surgeons and their staff. Reading User Guides The user guides describe complex medical devices and software that must be used with care. It is important that all users of system, instruments and software: Read the user guides carefully before handling the equipment Have access to the relevant user guides at all times Available User Guides User Guide Software User Guides Instrument User Guides Cleaning, Disinfection and Sterilization Guide System User Guides Technical User Guide Contents Overview of treatment planning and image-guided navigation Description of OR system setup Detailed software instructions Detailed instructions on instrument handling Details on cleaning, disinfecting and sterilizing instrumentation Comprehensive information on system setup Detailed technical information on the system, including specifications and compliances 14 Instrument User Guide Rev. 1.1 Hip

15 INSTRUMENTATION OVERVIEW 2 INSTRUMENTATION OVERVIEW 2.1 Instrument Handling Safety Critical Information Correct Handling The instruments described in this manual are highly accurate and sensitive medical devices and must be handled with extreme care. If you drop or otherwise damage an instrument, contact Brainlab immediately for advice on how to proceed. Failure to do so may lead to serious injury to the patient. Do not use damaged or corroded instruments. Plan the OR setup prior to surgery. The camera must have an unobstructed view of all marker spheres, otherwise registration and navigation inaccuracies may occur. Creutzfeldt-Jakob Contamination Do not use Brainlab instrumentation on patients suspected of having Creutzfeldt-Jakob disease (CJD or vcjd). MR Safety Unless otherwise noted, the instruments are MR unsafe. Sterilization Unless otherwise indicated, instruments must be sterilized before use. Details are provided in the Cleaning, Disinfection and Sterilization Guide. If a sterile instrument is inadvertently removed from the sterile field, it must be sterilized again. Instrument User Guide Rev. 1.1 Hip 15

16 Instrument Handling Using Fixation Pins General Information The placement of a fixation pin in bone structures is a standard minimally-invasive and low-risk surgical procedure that is required in order to provide a stable basis for attaching reference arrays and performing navigation. However, as an incision is required, please read the following information carefully before continuing. Risks Because placement of a fixation pin requires an incision, one or more of the following complications may occur: infection, local pain, bleeding, lesion of blood vessels or nerves, bone fracture or thrombosis. Placement of a fixation pin in the acetabulum may also cause lesions of the viscera. Precautions In some cases, fixation pins may be placed using an automatic drill, however, use only the lowest drilling speed to maintain maximum control over the drilling depth. Use only a threaded fixation pin with the specified diameter. Using a fixation pin with the incorrect diameter could result in unstable attachment. To ensure stable attachment, the fixation pin should be positioned bicortically where possible. 16 Instrument User Guide Rev. 1.1 Hip

17 INSTRUMENTATION OVERVIEW Available Instruments General Instrumentation Illustration Name See Disposable Reflective Marker Spheres Page 21 Disposable Schanz Screws Page 24 Instrument Calibration Matrix (Rev. 4) - ICM4 Page 25 Pointers Illustration Name See Pointer Straight Extended Page 29 Pointer Angled for Hip and Knee Page 29 Extended Pointer Sharp Tip Page 30 Disposable Clip-on Remote Control Page 31 Instrument User Guide Rev. 1.1 Hip 17

18 Instrument Handling Reference Arrays Illustration Name See Reference Array T-Geometry X-Press Page 46 Reference Array Y-Geometry X-Press Page 46 Bone Fixator 1-Pin, X-Press, Size-S/M/L Page 50 1-Pin Wrench X-Press/ Spine Clamps Page 51 Bone Fixator 2-Pin, Flip-Flop, X-Press Page Instrument User Guide Rev. 1.1 Hip

19 INSTRUMENTATION OVERVIEW Illustration Name See Pinless Femur Reference Array Page 65 Hip Caliper Page 43 Instrument Adapters - Hip Illustration Name See Instrument Adapter, StarLock Interface Page 70 Adapter for Cup Inserter Page 72 Cup Reamer Adapter Page 75 Femoral Broach Adapter DePuy Page 78 Instrument User Guide Rev. 1.1 Hip 19

20 Instrument Handling Cup Impactors Illustration Name See Straight Cup Impactor Universal Page 91 Offset Cup Impactor Universal Page 83 Insert For Cup Impactor Universal Page 101 Surgical Instruments Illustration Name See Stem Position Verification Tools Page 81 Drill Guide Page 103 Footswitch Illustration Name See Footswitch (USB) Page Instrument User Guide Rev. 1.1 Hip

21 GENERAL INSTRUMENTATION 3 GENERAL INSTRUMENTATION 3.1 Disposable Reflective Marker Spheres Overview General Information Figure 1 Product Pieces Article No. Available from Disposable Reflective Marker Spheres 90 (30 x 3) Brainlab and NDI 270 (90 x 3) Disposable Reflective Marker Spheres are attached to reference arrays and instruments, thus enabling the system to detect the position of the patient and instruments in the surgical field. Brainlab navigation systems can only be used with the above marker spheres. The use of other marker spheres could affect navigation accuracy, posing a risk to the patient. When to Attach Marker Spheres Attach marker spheres to instruments and arrays before calibration or use in surgery. Ensuring Sterility Marker spheres are delivered sterile. They cannot be resterilized and must be disposed of after use. Do not resterilize disposable reflective marker spheres as this reduces their accuracy, posing a risk to the patient. The reflective marker spheres are single use only. Instrument User Guide Rev. 1.1 Hip 21

22 Disposable Reflective Marker Spheres Using Marker Spheres Ensuring Navigation Accuracy Navigation accuracy critically depends on the condition of the marker spheres used. Verify prior to use that the reflective surface of all marker spheres is in good condition, and not peeling. Only use clean and dry marker spheres. Wet or soiled marker spheres must either be cleaned and dried before further use, or replaced. Do not use defective or deformed marker spheres as this negatively affects navigation, potentially harming the patient. Set up the OR prior to surgery to ensure the camera has an unobstructed view of all marker spheres on the instrument adapters and reference arrays. Do not mask or cover any marker spheres, otherwise navigation is not possible or may be inaccurate. How to Attach Marker Spheres Step Figure 2 Tightly screw marker sphere by hand onto each attachment pin of the instrument. Ensuring Secure Attachment Ensure that marker spheres can be screwed onto the pin until there is no gap between the sphere and the base of the pin. Do not use a marker sphere if it is not securely attached in this position. If excessive force is needed to screw a marker sphere onto its pin, dispose of the marker sphere and use a new one. If you use marker spheres on, or in the vicinity of, oscillating or vibrating instruments, check the marker spheres at regular intervals to ensure that they remain securely attached. 22 Instrument User Guide Rev. 1.1 Hip

23 GENERAL INSTRUMENTATION Cleaning Marker Spheres Only use a soft cloth moistened with sterile water to clean the surface of soiled marker spheres. Ensure that the cleaned marker sphere is absolutely dry before use. If you clean or replace a marker sphere on an instrument or reference array, verify navigation accuracy before continuing. Instrument User Guide Rev. 1.1 Hip 23

24 Disposable Schanz Screws 3.2 Disposable Schanz Screws Overview General Information Figure 3 Product Type Article No. 3.2 mm x 100 mm (10 pieces) (AO) 4 mm x 125 mm (10 pieces) (AO) 5 mm x 175 mm (10 pieces) Disposable Schanz Screws 3 mm / 100 mm (10 pieces) mm / 130 mm (10 pieces) mm / 150 mm (10 pieces) mm / 200 mm (10 pieces) Disposable Schanz Screws are used to attach e.g., bone fixators or cutting blocks directly to the bone of the patient. Only attach Schanz screws to bone structures, never to tissue or parts of the nervous system. Only use Brainlab Schanz screws. Sterility Schanz screws are delivered un-sterile and need to be sterilized before use. They cannot be resterilized and must be disposed of after use. Do not resterilize disposable Schanz screws as this poses a risk to the patient. 24 Instrument User Guide Rev. 1.1 Hip

25 GENERAL INSTRUMENTATION 3.3 Instrument Calibration Matrix (Rev. 4) - ICM4 (41874) ICM Features General Information The ICM4 is used: To calibrate the axis (and vector), diameter, planes and tips of non-precalibrated instruments so that they can be accurately navigated by the Brainlab software To verify and validate the calibration accuracy of precalibrated instruments The ICM4 can only be used with Brainlab navigation software. Instructions on calibrating instruments using the ICM4 are in your Software User Guide. ICM4 Features Figure 4 No Component Reference planes (examples) V-inset Calibration receptacles (examples) Pivot points Activation When the system detects the ICM4 in the camera field of view, the navigation software guides you through instrument calibration, validation, and /or verification. See your Software User Guide for more details. Instrument User Guide Rev. 1.1 Hip 25

26 Instrument Calibration Matrix (Rev. 4) - ICM4 (41874) V-Inset Figure 5 The V-insert is used to calibrate the long axis and vector of the instrument shaft. Calibration performed in the V-inset can be refined, if necessary, using the pivot holes or reference planes. Do not calibrate conical instruments using the V-inset. This results in the incorrect display of the instrument axis. Reference Planes 1 2 Figure 6 No. Plane Use 1 4 Reference for tip distance of instruments calibrated in the V-inset 2 3 Reference for shaft diameter of instruments calibrated in the V-inset 26 Instrument User Guide Rev. 1.1 Hip

27 POINTERS 4 POINTERS 4.1 Using Pointers Handling Pointers Pointer Functionality Pointers are used: To perform pointer-based patient registration To verify that registration accuracy is maintained To verify the accuracy of acquired fluoroscopic images Detailed instructions for use of pointers is provided in your Software User Guide. NOTE: Pointers are precalibrated. They can be used without any further calibration. Correct Handling of Pointers The marker spheres of the active pointer must be visible to the camera at all times during registration and navigation. If a pointer is indicated by the software for a registration step, use that pointer. Software Compatibility Your Software User Guide lists the pointers supported by your Brainlab navigation software. Instrument User Guide Rev. 1.1 Hip 27

28 Using Pointers Maintaining Pointer Accuracy Storage Each pointer comes with a gauge, that serves to prevent pointer damage and ensure maximum accuracy. Always sterilize pointers and store them in their designated inserts in the pointer gauge. Checking Pointer Accuracy Using the Pointer Gauge 1 2 Figure 7 If a pointer is undamaged, its tip 1 aligns with the corresponding counterpart of the gauge 2. Check pointer accuracy before each use. Ensure that the pointer tip aligns with the counterpart on the pointer gauge. 28 Instrument User Guide Rev. 1.1 Hip

29 POINTERS 4.2 Types of Pointers Overview The tips of the pointers are rounded off as a partial sphere, preventing the pointer tips from catching on bone or soft tissue and allowing smoother movement along the bone surface during registration and planning procedures. NOTE: For easier identification, each pointer has a different color indicator on the end of the handle. NOTE: The Pointer Extended for Hip and Pointer Angled for Hip and Knee share the same instrument geometry. Pointer Extended for Hip (53108) Figure 8 The Pointer Extended for Hip is a straight pointer with a longer stem. It enables easier point acquisition on larger patients and of deeper areas, such as the base of the acetabulum, during the registration process. It has a red color indicator. Pointer Angled for Hip And Knee (53101) Figure 9 The Pointer Angled for Hip and Knee facilitates point acquisition in deeper anatomical areas. It has a downward-curved tip, to enable camera tracking when acquiring registration landmarks at difficult angles. It has a black color indicator. Instrument User Guide Rev. 1.1 Hip 29

30 Types of Pointers Extended Pointer Sharp Tip (53102) Figure 10 The Extended Pointer Sharp Tip facilitates point acquisition in deeper anatomical areas. It also facilitates registration and navigation on larger patients. 30 Instrument User Guide Rev. 1.1 Hip

31 POINTERS 4.3 Disposable Clip-on Remote Control (53153) Overview General Information Figure 11 The Disposable Clip-on Remote Control enables active patient registration and software control in combination with existing Brainlab pointers. The Disposable Clip-on Remote Control is an active, non-invasive, single-use device and is delivered sterile in sterile packaging. Supported Pointers The Disposable Clip-on Remote Control can be used with the following pointers: Pointer Extended for Hip Pointer Angled for Hip and Knee Extended Pointer Sharp Tip Instrument User Guide Rev. 1.1 Hip 31

32 Disposable Clip-on Remote Control (53153) Attaching the Disposable Clip-on Remote Control Device Overview Figure 12 No. Component Function 1 Control button Activates infrared LED 2 Infrared LED Detected by camera, but not visible to naked eye 3 Green status LED Indicates battery status and functionality 4 Center opening Attachment interface to pointer Before Use Steps 1. Remove the Disposable Clip-on Remote Control from its sterile package. 2. Perform a functionality check by pressing the control button 1 and ensuring that: The status LED 3 is on The infrared LED 2 is displayed as a colored flash on the camera display of the navigation screen Verify prior to opening the sterile packaging that the expiration date has not lapsed and the package is not damaged. If the expiration date has lapsed or if damage is present, do not use the Disposable Clip-on Remote Control, and dispose of it immediately. If battery leakage is visible inside the sterile packaging, do not open and dispose of the Disposable Clip-on Remote Control immediately. Do not use if the packaging is broken. Ensuring Sterility The Disposable Clip-on Remote Control is delivered sterile. If any of the sterile components come into contact with an unsterile environment during unpacking or clinical use, dispose of the device immediately. 32 Instrument User Guide Rev. 1.1 Hip

33 POINTERS How to Attach the Disposable Clip-on Remote Control to the Pointer Figure 13 Steps 1. Attach the Disposable Clip-on Remote Control by placing the center opening 2 over the indicated attachment pin 1 on the pointer handle. NOTE: Before attaching, consider the position depending on whether the user is 4 lefthanded or right-handed Snap the Disposable Clip-on Remote Control fully onto the pointer handle. 3. Attach marker spheres 3 to the pointer (see page 21). NOTE: When using the pointer, we recommend holding the pointer with the Disposable Clip-on Remote Control between the thumb and middle finger, pressing the control button with the index finger. Ensuring Correct Attachment Plan the position of the Disposable Clip-on Remote Control accordingly for a left- or righthanded user, as well as the OR setup prior to surgery. The camera must have an unobstructed view of the reflective marker spheres and infrared LED. Make sure to properly attach the Disposable Clip-on Remote Control to the attachment pin on the pointer, and to completely screw the Disposable Reflective Marker Sphere until there is no gap between the sphere and the base of the pin. Instrument User Guide Rev. 1.1 Hip 33

34 Disposable Clip-on Remote Control (53153) Using the Disposable Clip-on Remote Control General Information When you press the control button, the infrared LED is activated and can be tracked by the camera on the navigation system. The infrared LED is displayed as a colored flash in the camera display on the navigation screen. Depending on the software application, the infrared LED signal can be used for various functions, for example, acquisition of surface points during registration. NOTE: During use, make sure that the infrared LED is visible to the camera, and that it is not contaminated, e.g., with blood. Verify the functionality of infrared LED prior to use by checking the status LED on the Disposable Clip-on Remote Control and the camera display on the navigation screen. Further Information Refer to your corresponding Software User Guide for more information on using the Disposable Clip-on Remote Control in combination with the software. Correct Instrument Handling During point acquisition, always make sure that the pointer tip has contact with the patient or bone when activating the Disposable Clip-on Remote Control. Do not press on the housing of the Disposable Clip-on Remote Control where LEDs are located. Safety Consideration Do not look directly into infrared LED of Disposable Clip-on Remote Control at a close distance when the control button is activated. 34 Instrument User Guide Rev. 1.1 Hip

35 POINTERS After Use Detaching and Disposing of the Disposable Clip-on Remote Control The Disposable Clip-on Remote Control is a single-use device and cannot be sterilized. Remove it from the pointer and dispose of after use. Steps 1. Following use, remove the Disposable Clip-on Remote Control from the pointer. 2. Prior to disposal, clean all surfaces with a surface disinfectant If required, open the housing at the notch 1 with a small sharp tool and remove the battery 3 and electronics 2 for separate disposal. Correct Handling During Disposal Do not re-use or replace battery and do not autoclave the Disposable Clip-on Remote Control after use. This will destroy the device and might lead to severe damage of autoclaving equipment or injury to patient and user. No modification of the device is allowed. Do not completely immerse Disposable Clip-on Remote Control into any liquids. The Disposable Clip-on Remote Control contains a primary lithium cell. Consider disinfecting device after use and disposing of it separately. For disposal of the contained electronics and primary lithium cell, check with your local environmental protection and waste agency for special disposal restrictions. Instrument User Guide Rev. 1.1 Hip 35

36 Disposable Clip-on Remote Control (53153) Technical Specifications Dimensions and Weight Dimension Height Length Width Weight Value 17.3 mm 53.9 mm 27.0 mm 12 g Electrical Specification Description Power Supply 3 V primary lithium cell CR2032 Power Consumption max. 36 mw Current 12 ma, direct current (DC) Electrical Safety Compliance with IEC LEDs Specification Infrared LED Status LED Wavelength 870 nm 570 nm Viewing Angle at 50% Intensity Photobiological Safety Compliance with IEC Compliance with IEC Housing Specification IP Classification Description Materials Polyamide 12 IP44 according to IEC (protected against particles > 1 mm and against splashing liquids) Environmental Specifications Storage Conditions Operating Conditions Temperature 0 C to 35 C (32 F to 95 F) 10 C to 40 C (50 F to 104 F) Humidity 15% to 80% non-condensing 20% to 80% non condensing Pressure 700 hpa to 1060 hpa 700 hpa to 1060 hpa Disposal According to local environmental waste regulations 36 Instrument User Guide Rev. 1.1 Hip

37 POINTERS Sterility and Usability Specification Sterility Status Method Shelf Life Usability Description Sterile Ethylene-oxide Three years Single use Instrument User Guide Rev. 1.1 Hip 37

38 Disposable Clip-on Remote Control (53153) Electromagnetic Compatibility and Emissions Electromagnetic Compatibility: Declaration For medical electrical devices, special safety measures with respect to electromagnetic compatibility must be considered. Devices can only be installed and used in accordance with corresponding electromagnetic compatibility guidelines as described in this user guide. Portable or mobile RF communication devices may influence the intended functionality of medical electrical equipment. Electromagnetic Environment The Disposable Clip-on Remote Control is intended for use in the electromagnetic environment specified in the tables provided in this section. The customer or the user should assure that the Disposable Clip-on Remote Control is used in such an environment. RF Emissions Interferences The Disposable Clip-on Remote Control only uses RF energy for internal functions. For this reason, the RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Declaration Guidance and manufacturer s declaration regarding electromagnetic emissions: Emissions Test Compliance Electromagnetic Environment - Guidance RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 1 Class B Not applicable Not applicable The Disposable Clip-on Remote Control is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 38 Instrument User Guide Rev. 1.1 Hip

39 POINTERS Electromagnetic Immunity Electromagnetic Environment The Disposable Clip-on Remote Control is intended for use in the electromagnetic environment specified in the tables provided in this section. The customer or the user should assure that the Disposable Clip-on Remote Control is used in such an environment. Electromagnetic Immunity Declaration The tables in the following sections provide the guidance and manufacturer s declaration regarding electromagnetic immunity. IEC , IEC Immunity Test Electrostatic discharge (ESD) IEC Power frequency (50/60 Hz) magnetic field IEC IEC Test Level and Compliance Level 6 kv contact +/- 8 kv air 3 A/m Electromagnetic Environment- Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. IEC ,IEC Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Disposable Clip-on Remote Control, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: Conducted RF IEC Veff 150 khz to 80 MHz 3 V 1.2 * P Radiated RF IEC V/m 80 MHz to 2.5 GHz 3 V/m 1.2 * P (80 MHz to 800 MHz) 2.3 * P (800 MHz to 2.5 GHz) where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with this symbol. Instrument User Guide Rev. 1.1 Hip 39

40 Disposable Clip-on Remote Control (53153) Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance NOTE: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular /cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Disposable Clip-on Remote Control is used exceeds the applicable RF compliance level above, the Disposable Clip-on Remote Control should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocation the Disposable Clip-on Remote Control. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than [V1] V/m. 40 Instrument User Guide Rev. 1.1 Hip

41 POINTERS RF Communications Equipment Effects on the Device Portable and mobile RF communications equipment can affect the Disposable Clip-on Remote Control. Electromagnetic Environment The Disposable Clip-on Remote Control is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Disposable Clip-on Remote Control can help prevent electromagnetic interference. This is accomplished by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Disposable Clip-on Remote Control as recommended below, according to the maximum output power of the communications equipment. Separation Distances Separation distances between portable and mobile RF communications equipment and the Disposable Clip-on Remote Control: Rated Maximum Output Power of Transmitter Separation Distance According to Frequency of Transmitter m W 150 khz to 80 MHz 1.2 * P 80 MHz to 800 MHz 1.2 * P 800 MHz to 2.5 GHz 2.3 * P For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Instrument User Guide Rev. 1.1 Hip 41

42 Footswitch (USB) (18460) 4.4 Footswitch (USB) (18460) Overview General Information Figure 14 The Footswitch (USB) enables patient registration to be performed with reduced touchscreen interaction. The Footswitch (USB) uses the USB connection to the navigation system, e.g., Curve or Kick. NOTE: The footswitch activates automatically when plugged-in. Footswitch Pedal Functions Pedal Blue Yellow Black Function Register landmarks or selects element marked in blue. Selects element marked in yellow. Cycles through controllable elements in navigation and planning. How to Use a Footswitch Refer to your corresponding Software User Guide for more information on using the Footswitch (USB) in combination with the software. 42 Instrument User Guide Rev. 1.1 Hip

43 HIP CALIPER 5 HIP CALIPER 5.1 Hip Caliper (52876) Using the Hip Caliper General Information Figure 15 The Brainlab Hip Caliper is used to define the distance on distinctive ASIS points for navigated hip surgery using a Brainlab navigation system. This information is required for pelvis definition and navigation of hip implants. The Hip Caliper is intended to be used prior to surgery on intact skin. The degree of accuracy of the device is determined to be +/- 1 mm. The Hip Caliper is not intended for use with any other application or measurements. The device shall only be used on intact skin. Sterilize the device if it comes in contact with blood. Instrument User Guide Rev. 1.1 Hip 43

44 Hip Caliper (52876) How to Use the Hip Caliper 1 2 Figure 16 Steps 1. Define two distinctive ASIS landmarks 1. NOTE: The one on the treated patient side is relocated during subsequent patient registration. 2. Place the center of the Hip Caliper markers on top of these points Note the value displayed in the inspection window 2. The Hip Caliper is a highly accurate and sensitive device. To maintain calibration precision, it must be handled with extreme care. If it is dropped or damaged, contact Brainlab immediately for advice on how to proceed. 44 Instrument User Guide Rev. 1.1 Hip

45 REFERENCE ARRAYS, X-PRESS 6 REFERENCE ARRAYS, X- PRESS 6.1 Instrument Overview Introduction General Information The Reference Arrays, X-Press are reference array attachment systems that have: An adjustment joint to orient the reference array optimally for the camera field of view. A quick fastener mechanism to remove the Reference Array, X-Press during surgery whenever it is not actively needed for navigation, and replace it in the same orientation so that no registration information is lost. A complete functional Reference Array, X-Press comprises the following: A reference array (Y or T geometry) that enables tracking of the patient s bone A bone fixator (1-pin or 2-pin) that provides the interface between the reference array and the bone One or two Schanz screws Assembled Reference Arrays, X-Press 1 2 Figure 17 No. 1 2 Reference Array X-Press Y geometry, attached to a 1-pin bone fixator T geometry, attached to a 2-pin bone fixator NOTE: Either reference array can be used in combination with either the Bone Fixator 1-Pin, X-Press or the Bone Fixator 2-Pin, Flip-Flop, X-Press. Instrument User Guide Rev. 1.1 Hip 45

46 Instrument Overview Reference Array, X-Press Kits About Kits Reference Array, X-Press components can be ordered separately or as part of an applicationspecific kit. The exact components of an Reference Array, X-Press kit depend on the intended surgical procedure. Reference Array Kit, X-Press Components Figure 18 No. Component 1 1-Pin Wrench, X-Press (52424) 2 Bone Fixator 1-Pin, X-Press: S (52421), M (52422), and L (52423) (see page 50) 3 Reference Array T Geometry (52410) and Reference Array Y Geometry (52411) (see page 56) 4 Bone Fixator 2-Pin, Flip-Flop, X-Press (52429) (see page 53) 46 Instrument User Guide Rev. 1.1 Hip

47 REFERENCE ARRAYS, X-PRESS 6.2 Bone Fixators, X-Press Overview General Information Bone fixators provide the interface between X-Press reference arrays and bone. They are affixed to bone via Schanz screws. The Bone Fixator 1-Pin or 2-Pin, Flip-Flop, X-Press must be used with an X-Press reference array. Place bone fixators so that the alignment of the reference array will not hinder the use of any other instrumentation, such as attachment of a cutting block and its adapter. Always take the size of the implant components into account when placing the Schanz screw of the reference array. If there is a collision during implantation, the arrays have to be removed. Always leave sufficient space to enable incision, implant positioning and cup reaming or drilling without moving the reference arrays. Available Bone Fixators 1 2 Figure 19 No. 1 2 Bone Fixator 1-Pin, X-Press 2-Pin, Flip-Flop, X-Press Instrument User Guide Rev. 1.1 Hip 47

48 Bone Fixators, X-Press Using Schanz Screws with Bone Fixators Before Using Read the section referring to the use of fixation pins on page 16. Rotation of Bone Fixators on Schanz Screws 1 2 Figure 20 No. Bone Fixator Rotation possible? 1 1-Pin, X-Press Yes, before fixation 2 2-Pin, Flip-Flop, X-Press No Only attach Schanz screws to bone structures, never to tissue or parts of the nervous system. The Bone Fixator 2-Pin, Flip-Flop, X-Press does not support rotation around the Schanz screw. Therefore, consider the orientation of the bone fixator and reference array prior to inserting the Schanz screws into the bone, to ensure marker spheres are visible to the camera. Because the Bone Fixator 1-Pin, X-Press can be rotated around the Schanz screw axis, place the spike tube directly on the surface of the bone without penetrating soft tissue. Consider this when making the incision, prior to Schanz screw fixation. Required Schanz Screw Size Bone Fixator Required Schanz screw diameter and Article Number 1-Pin, X-Press 5 mm (54902 / / 54909) 2-Pin, Flip-Flop, X-Press 3 mm (54900) 3.2 mm (54922) - Pin driver Adapter for AO coupling (54932) 4 mm (54901 / 54908) A combination using these screw types is also possible. Only use bone fixators with threaded Schanz screws with the diameters specified above. The length of the thread must allow bicortical fixation. 48 Instrument User Guide Rev. 1.1 Hip

49 REFERENCE ARRAYS, X-PRESS Unicortical fixation, or using Schanz screws thinner than specified, may result in unstable attachment or cause the Schanz screw to be inadvertently pulled from the bone when the bone fixator is tightened. Do not use Schanz screws longer or thinner than specified, as they may bend or warp, leading to inaccurate navigation and potential injury to the patient. Avoid multiple drilling attempts when placing Schanz screws, this weakens the bone and may increase the risk of post-operative stress fracture. Stop drilling the Schanz screw when the opposite cortical bone is reached. Instrument User Guide Rev. 1.1 Hip 49

50 Bone Fixators, X-Press Using the Bone Fixator 1-Pin, X-Press Components The Bone Fixator 1-Pin, X-Press comes in three sizes: S (52421), M (52422), and L (52423). Make sure that you select the appropriate size for the procedure Figure 21 No Component Inlay Fixation screw NOTE: The fixation screw is available as a spare part, and should be replaced if it does not operate smoothly. Traction nut Spike tube Interface plate 50 Instrument User Guide Rev. 1.1 Hip

51 REFERENCE ARRAYS, X-PRESS How to Assemble the Bone Fixator Bone fixators should only be disassembled for cleaning. Reassemble them for sterilization and store them assembled in their sterilization tray Figure 22 Steps 1. Screw the fixation screw 2 into the inlay Screw the traction nut 3 onto the inlay Screw 1,2 and 3 into the spike tube 4. NOTE: Each part is engraved with a part number for easy identification. How to Attach the Bone Fixator Figure 23 Steps 1. Slide assembled bone fixator over Schanz screw 6. Instrument User Guide Rev. 1.1 Hip 51

52 Bone Fixators, X-Press Steps 2. Attach reference array to the bone fixator. Ensure that there is no space between traction nut 3 and the inlay. Ensure that the necessary reference array orientation is possible from the bone fixator s current position. 3. Secure bone fixator by tightening fixation screw 2 with the wrench. 4. Tighten traction nut 3 with the wrench. Safe Attachment If you make a small incision in the bone for attachment of the fixator, place the Schanz screw into the incision first. You can then slide the bone fixator over the Schanz screw down onto the surface of the bone. This prevents the spike tube from causing unnecessary abrasion of surrounding soft tissue. Securing the 1-Pin Bone Fixator Before tightening the Bone Fixator 1-Pin, X-Press to the Schanz screw, attach the Reference Array, X-Press and adjust it to ensure the camera has full view of the reference array. Never unscrew the Schanz screw if the Bone Fixator 1-Pin, X-Press is still attached, as this will cause extreme abrasion of the corticalis. Only consider doing so if the device cannot be removed using the standard procedure. Ensure that all screw connections are securely tightened before beginning patient registration. Any movement of the bone fixator during or after patient registration will result in inaccurate navigation. 52 Instrument User Guide Rev. 1.1 Hip

53 REFERENCE ARRAYS, X-PRESS Bone Fixator 2-Pin, Flip-Flop, X-Press (52429) General Information The Bone Fixator 2-Pin, Flip-Flop, X-Press has: A wedge-shaped clamping device that allows you to secure it tightly to two Schanz screws inserted in the bone A double-sided interface plate for attachment of an X-Press Reference Array Components Figure 24 No Component Fix knob Holes for attachment to Schanz screws Interface plate Schanz Screw Placement Do not use the interface plate 3 on the bone fixator as a template for Schanz screw placement. Otherwise wear will lead to inaccurate navigation, resulting in patient injury. Make sure to place the Schanz screws the correct distance apart when using the Bone Fixator 2-Pin, Flip-Flop, X-Press. You can use the holes of the bone fixator to estimate the correct placement. If the Schanz screws are too close together or too far apart, this can cause the screws to stretch during attachment of the fixator, irreparably damaging them. Instrument User Guide Rev. 1.1 Hip 53

54 Bone Fixators, X-Press Attaching the Bone Fixator 2-Pin, Flip-Flop, X-Press How to Attach the Bone Fixator 1 2 Figure 25 Steps Slide the assembled fixator over the Schanz screws 1. NOTE: If necessary, the fixator can be flipped over, as the reference interface can be used on both sides. Verify that the necessary reference array orientation is possible with the bone fixator in its current position. 3. Tighten the fix knob 2 by hand. The Bone Fixator 2-Pin, Flip-Flop, X-Press can be sufficiently tightened by hand. To avoid damaging the Schanz screws, make sure that the fix knob is open when drilling the Schanz screws directly through the respective holes of the Bone Fixator 2-Pin, Flip- Flop, X-Press. Safe Attachment The Bone Fixator 2-Pin, Flip-Flop, X-Press should be attached to Schanz screws affixed to bony structures covered with thin tissue. Use only Schanz screws from Brainlab. If the screws are too short, the overlying tissue may be too thick to allow stable fixation. Do not attach the Bone Fixator 2-Pin, Flip-Flop, X-Press to bone areas covered by strong muscle. Avoid piercing muscle tissue when attaching the bone fixator. Extensive muscle movement may cause the pin to bend. This can irreparably damage the Schanz screw and reduce navigation accuracy. 54 Instrument User Guide Rev. 1.1 Hip

55 REFERENCE ARRAYS, X-PRESS Securing the 2-Pin Bone Fixator Attach Bone Fixator 2-Pin, Flip-Flop, X-Press as close as possible to the bone or tissue surface for optimum stability. Tightly fasten fix knob before patient registration. When using Schanz screws with a special quick coupling interface e.g., AO quick coupling, do not use the drill template as the screw end is bigger than the drill template holes, making it impossible to remove the drill template after drilling. To achieve a stable connection and to avoid damage to the bone fixator, only attach it to parts of Schanz screws that have a circular cross section. Safe Removal If the bone fixator cannot be lifted off of the Schanz screws for any reason, the screws can be cut below the fixator and unscrewed separately. Instrument User Guide Rev. 1.1 Hip 55

56 Reference Arrays, X-Press 6.3 Reference Arrays, X-Press Reference Array, X-Press Overview Assembled Reference Arrays 1 2 Figure 26 No. Reference Array 1 Y geometry (52411) 2 T geometry (52410) Ensure that the T-geometry and Y-geometry are placed correctly. The T-geometry is pelvis only, and the Y-geometry is femur only. How to Assemble the Reference Array, X-Press 1 2 Figure 27 Step Screw clamp screw 2 into quick fastener Instrument User Guide Rev. 1.1 Hip

57 REFERENCE ARRAYS, X-PRESS Array Extension (52417) General Information The Array Extension provides an optional extension for the Reference Array, X-Press, and is used in combination with the Bone Fixator 1-Pin, X-Press, size small. Only use the Array Extension with the size small Bone Fixator 1-Pin, X-Press. Attaching the Array Extension to a medium or large bone fixator increases the risk of unintentional bending resulting in less accurate navigation. Illustration Figure 28 Instrument User Guide Rev. 1.1 Hip 57

58 Reference Arrays, X-Press Attachment Overview The Array Extension is connected between the quick fastener on the Reference Array, X-Press and the array itself Figure 29 No Component Reference array Clamp screw Array Extension Extension screw Quick fastener on the reference array Bone Fixator 1-Pin, X-Press How to Attach the Array Extension Steps 1. Screw clamp screw 2 into Array Extension Screw extension screw 4 into quick fastener 5. Do not use more than one Array Extension with the reference array as the use of more than one extension would reduce navigation accuracy. If the Bone Fixator 1-Pin, X-Press size small cannot be securely attached to the bone through the main incision, make a second incision in an area with less tissue covering the 58 Instrument User Guide Rev. 1.1 Hip

59 REFERENCE ARRAYS, X-PRESS bone. Secure fixation of the bone fixator to the bone is critical to ensure accurate navigation. During Surgery When using a reference array with the Array Extension, avoid heavy impacts to the patient or to the navigated bone as this may cause unintended bending of the array. Ideally, you should remove the reference array using the quick fastener mechanism (see page 60) for any steps that require impact to the patient or bone. The reference array can be reattached without losing registration information. Instrument User Guide Rev. 1.1 Hip 59

60 Reference Arrays, X-Press Attaching and Detaching the Reference Array How to Attach a Reference Array to a Bone Fixator Figure 30 Steps 1. Pinch the sides of quick fastener clamp 1 to open clamp jaws Insert stem pins of the quick fastener into corresponding holes on the interface plate of the bone fixator (arrow). Release quick fastener clamp and ensure that fixation hooks 2 are seated securely in corresponding notches 3 on the interface plate. If you cannot insert the pins of the array completely into the interface plate, contact Brainlab immediately for advice on how to proceed. Using damaged equipment could severely injure the patient. After Attachment Do not apply any force or torque to the bone fixators or reference arrays once they have been attached to the patient. Detaching the Reference Array To detach the array, pinch open the clamp jaws and lift the array straight up out of the interface plate. When removing the reference array during surgery, only use the quick fastener. Do not loosen the screw nut on the bone fixator. Handle the Reference Array, X-Press with extreme care if it is detached for any reason during surgery. Damage to the marker sphere pins could lead to inaccurate navigation and patient injury. 60 Instrument User Guide Rev. 1.1 Hip

61 REFERENCE ARRAYS, X-PRESS Reference arrays can be removed during sawing, minimizing movement risk. Applying excess force on the screw (e.g., using pliers) could cause it to break. Instrument User Guide Rev. 1.1 Hip 61

62 Reference Arrays, X-Press Preparation for Registration Optimizing Array Visibility The system recognizes a reference array by the geometrical arrangement of its marker spheres. The angle for best detection of the array is perpendicular to the plane through the centers of all marker spheres in the array. Take this into account when attaching a reference array to the patient or adjusting its angle to the camera for use. Figure 31 The camera s ability to recognize an array is highest when the plane through the marker spheres on the array is perpendicular to the viewing direction of the camera. How to Adjust Array Orientation Use the adjustment joint of the Reference Array, X-Press to orient array so that the camera has the best view of the array for tracking purposes. 2 1 Figure 32 Steps 1. Loosen quick fastener clamp screw Adjust reference array pitch by lifting or lowering array around quick fastener clamp joint. 3. Adjust reference array side-to-side, tilt by rotating it around its shaft. 4. Tighten quick fastener clamp screw by hand. Make sure that the joint teeth are positioned within the grooves. The adjustable joint can be sufficiently secured by tightening the locking screw by hand. Do not use tools, as this may damage the components. 62 Instrument User Guide Rev. 1.1 Hip

63 REFERENCE ARRAYS, X-PRESS Avoiding Teeth-on-Teeth Alignment To ensure a secure connection, make sure that the teeth on the adjustable joints of the reference array are in the corresponding grooves, not on other teeth. Figure 33 Avoiding Unstable Joint Alignment An audible click indicates that the second joint is in the correct stable position 1. Do not position or tighten the second joint in an unstable position Figure 34 Before Registration Attach marker spheres to reference array. For further information, see page 22 Check regularly that marker spheres remain tightly attached to reference array. Instrument User Guide Rev. 1.1 Hip 63

64 Reference Arrays, X-Press Tighten screws of the adjustable joints before patient registration. Movement of the Reference Array, X-Press during or after patient registration will result in inaccurate navigation. Before registration, check that the range of motion is sufficient and the bone fixator does not encounter any heavy tissue. If tissue collision is likely to occur, enlarge the incision to reduce tension on the bone fixator. Failure to do so may bend or loosen the bone fixator, causing navigation to be inaccurate. 64 Instrument User Guide Rev. 1.1 Hip

65 PINLESS FEMUR REFERENCE ARRAY 7 PINLESS FEMUR REFERENCE ARRAY 7.1 Instrument Overview Introduction About the Array The Pinless Femur Reference Array allows the leg length of the treated femur to be determined during surgery for comparison purposes. These measurements are acquired without additional pins or incisions. Pinless Femur Reference Array (52400) Figure 35 No. Component Explanation 1 Reference array Enables patient tracking. 2 Base plate Provides base to attach the array to the leg. 3 Fixation screw with pointed tip Punctures through the sterile drape and fastens the array to the base plate Instrument User Guide Rev. 1.1 Hip 65

66 Instrument Overview Attaching the Base Plate and Reference Array Preparation Before attaching the Pinless Femur Reference Array, prepare the patient for surgery and position the patient appropriately in the operating room. When planning the reference array orientation, bear in mind that the reflective marker spheres must be visible to the camera at all times. Marker Sphere Attachment If not already attached, tightly screw reflective marker spheres onto the attachment pins of the reference array. For further information see page 22. Base Plate Positioning 2 1 Figure 36 No. 1 2 Component Sterile environment after pelvis registration Side to be treated 66 Instrument User Guide Rev. 1.1 Hip

67 PINLESS FEMUR REFERENCE ARRAY How to Attach the Pinless Femur Reference Array 1 Figure 37 Steps Create a sterile environment on the patients pelvis area and on the femur on the treatment side. Place the base plate onto the distal femur on the treatment side to enable the reference array to be attached as distally as possible. 3. Use the sterile self-adhesive drape 1 to fix the base plate to the femur. 4. Wrap the drape around the leg until the base plate is securely fixed to the femur. 5. Puncture the drape with the pointed tip of the fixation screw and secure the array with the screw. NOTE: Puncture the drape near the threading of the base plate. Because the base plate is sterile, sterility is not influenced. Use of Self-Adhesive Drape The base plate is initially fixed to the patient with strips of adhesive tape. For final fixation, the leg drape can be pulled over the base plate. The self-adhesive drape is not intended to create a sterile environment, but to affix the base plate to the femur of the patient. Ensuring the Reference Array Attachment The base plate must be securely fixed to the patient to prevent it from tilting. Tilting could cause inaccurate navigation. Avoid bedsores near the area where the device is attached to the patient's femur by not tightening the drape too tightly. Instrument User Guide Rev. 1.1 Hip 67

68 Instrument Overview 68 Instrument User Guide Rev. 1.1 Hip

69 INSTRUMENT ADAPTERS 8 INSTRUMENT ADAPTERS 8.1 Using Adapters Overview Optimizing Array Angle for Tracking The system recognizes an instrument by the geometrical arrangement of the marker spheres on its tracking array. For the system to identify an instrument, the camera must have a clear view of its marker spheres. The camera viewing angle for best recognition of the array is perpendicular to the plane through the centers of all marker spheres in the array. 1 2 You can optimize the visibility of instruments by: Figure 38 Optimally positioning the camera in the operating room (see the Software User Guide) Orienting arrays on instruments so that during navigation their full geometry is visible to the camera No. 1 2 Component Optimal viewing angle Least effective viewing angle Attachment Position Attach the tracking array so that the longest arm of the array at 90 to the instrument axis. Calibration Attach reflective marker spheres to the array before calibrating the instrument. Ensure that all instrument adapter screws and knobs are securely tightened. Instrument User Guide Rev. 1.1 Hip 69

70 Instrument Adapter, StarLock Interface (55080, 55085) 8.2 Instrument Adapter, StarLock Interface (55080, 55085) Overview General The StarLock Instrument Adapter uses a bayonet-style connector to enable rapid attachment and removal of a tracking array. It is compatible with precalibrated instruments or 3rd-party instruments to which a StarLock Adapter Base has been attached. StarLock Adapter 1 2 Figure 39 No. 1 2 Component Tracking array Locking sleeve 70 Instrument User Guide Rev. 1.1 Hip

71 INSTRUMENT ADAPTERS Attaching the StarLock How to Attach the StarLock Figure 40 Steps Insert the stem of the StarLock adapter 3 into the base 4, making sure that the engraved arrows are aligned. Push down the locking sleeve 2, turn it clockwise, and release it so that the locking pins are in the bayonet slots Verify that there is no gap visible between instrument and adapter. The StarLock adapter base should not be soiled with blood or cell tissue. Instrument User Guide Rev. 1.1 Hip 71

72 Adapter for Cup Inserter (41851) 8.3 Adapter for Cup Inserter (41851) Overview General Information The Adapter for Cup Inserter allows you to navigate the axial direction and depth of cup inserters. Adapter for Cup Inserter Figure 41 No Component Tracking array Wrench Clamp bolt Instrument clamp Instrument Compatibility The Adapter for Cup Inserter has been approved for use with any cup inserter having a straight, cylindrical shaft with a diameter between mm. Do not use the adapter with inserters that have a curved shaft. For more information on compatibility, see the Software User Guide. If the Adapter for Cup Inserter is used on instruments with a diameter outside the specified diameter parameters, proper fixation cannot be guaranteed, especially in the case of vibrations. Using the instrument adapter with a curved cup inserter may result in inaccurate instrument tracking, which could be hazardous to the patient. Using a cup inserter other than that specified by the implant manufacturer may lead to miscalibration of the cup inserter. 72 Instrument User Guide Rev. 1.1 Hip

73 INSTRUMENT ADAPTERS Attaching the Adapter for Cup Inserter Where to Attach the Adapter for Cup Inserter Figure 42 Position the adapter so that it will not come into contact with patient tissue while the instrument is in use. Attach the Adapter for Cup Inserter as close to the handle of the cup inserter as possible. How to Mount the Adapter for Cup Inserter 2 1 Steps Figure Mount the adapter onto the inserter shaft as close to the handle as possible Adjust the position of the adapter so that it will not interfere with the surgeon s work during surgery. Tighten the clamp bolt 2 using the supplied wrench 1. NOTE: Further adjustments are not possible after tightening the clamp bolt. 4. Calibrate the instrument using the ICM4 after mounting the adapter to the cup inserter. Instrument User Guide Rev. 1.1 Hip 73

74 Adapter for Cup Inserter (41851) Use the supplied wrench to tighten the clamp bolt to prevent the adapter from moving. Mount the Adapter for Cup Inserter onto the inserter shaft as close to the handle as possible. 74 Instrument User Guide Rev. 1.1 Hip

75 INSTRUMENT ADAPTERS 8.4 Cup Reamer Adapter (41879) Overview General Information The Cup Reamer Adapter may only be used with the compatible cup reamer handles. For more information on compatibility, see the Software User Guide. The Cup Reamer Adapter may only be used in combination with specified instruments. Brainlab does not assume liability if the Cup Reamer Adapter is used in combination with non-approved instruments. Cup Reamer Adapter Components 1 2 Figure 44 No. 1 2 Component Adjustment nut Counter nut How to Assemble Step Screw the counter nut 2 and adjustment nut 1 onto the Cup Reamer Adapter. Instrument User Guide Rev. 1.1 Hip 75

76 Cup Reamer Adapter (41879) Attaching the Cup Reamer Adapter Before You Begin Note the specific instructions for each manufacturer. Options If you are using a Precimed EZ-Clean reamer handle, attach the ring and sleeve before attaching the adapter to the instrument. If you are using a cup reamer from any other manufacturer, attach the adapter directly to the handle. How To Attach the Ring and Sleeve (Precimed Only) 3 4 Figure 45 Steps 1. Before attaching the Cup Reamer Adapter, slide the ring 3 over the reamer shaft. 2. Slide the sleeve 4 over the reamer shaft. How To Attach the Cup Reamer Adapter 5 21 Figure 46 Steps 1. If you are using a Precimed EZ-Clean cup reamer handle, attach the ring. 2. Slide the adapter over the reamer shaft (or the sleeve, in the case of Precimed). 3. Make sure that the arrow 5 on the Cup Reamer Adapter points toward the head of the cup reamer handle. 4. Tighten the adjustment nut Instrument User Guide Rev. 1.1 Hip

77 INSTRUMENT ADAPTERS Steps 5. Tighten the counter nut 2. Make sure that the reamer can still be easily rotated. Tight attachment ensures accurate reamer navigation. The Cup Reamer Adapter may only be attached to the reamer handle with the arrow pointing towards the head of the cup reamer handle. Make sure that both the counter and adjustment nuts are properly tightened before navigation. Always use the Cup Reamer Adapter, with it pushed forward as close as possible towards the head of the reamer handle. This ensures maximum accuracy. Attaching the Clip 6 7 Figure 47 Step If you are using a Precimed or Zimmer Full Hemisphere reamer handles, attach the clip 6 between the Cup Reamer Adapter and the notch 7 on the reamer shaft. NOTE: If you are using a cup reamer from any other manufacturer, it is not necessary to attach a clip. Correct Instrument Handling Do not use the Cup Reamer Adapter if you notice critical inaccuracies or loose attachment, even after tightening. In such cases, contact Brainlab immediately for advice on how to proceed. Instrument User Guide Rev. 1.1 Hip 77

78 Femoral Broach Adapter DePuy (41852) 8.5 Femoral Broach Adapter DePuy (41852) Overview General Information The Femoral Broach Adapter DePuy may only be used in combination with selected DePuy broaches. Femoral Broach Adapter DePuy Figure 48 No Component Screwdriver Screw Tracking array Correct Instrument Handling Using a hammer to insert the broach may cause the marker spheres to loosen. Check the marker spheres at regular intervals to make sure that they remain securely attached. The Femoral Broach Adapter DePuy may only be used with specially-modified broach handles. 78 Instrument User Guide Rev. 1.1 Hip

79 INSTRUMENT ADAPTERS Attaching the Femoral Broach Adapter DePuy How to Attach the Femoral Broach Adapter DePuy 1 2 Figure 49 Steps 1. Insert the adapter into the insertion hole on the broach handle. 2. Make sure that the engraving on the adapter is aligned with the marking on the broach Tighten the adapter. The supplied screw was specially developed to withstand sustained impact. Only use this screw and the supplied screwdriver to tighten or adjust the screw 2. Correct Handling Only use the wrench provided by Brainlab to tighten the adapter. This protects the screw and ensures a stable connection. To ensure that the adapter is properly aligned, it must be inserted into the designated opening on the modified broach handle, and aligned using the arrow on the adapter and the marking on the broach handle. Instrument User Guide Rev. 1.1 Hip 79

80 Femoral Broach Adapter DePuy (41852) 80 Instrument User Guide Rev. 1.1 Hip

81 SURGICAL INSTRUMENTS 9 SURGICAL INSTRUMENTS 9.1 Stem Position Verification Tools Overview Use The Brainlab Stem Position Verification Tools are attached to an inserted stem implant to verify stem placement. Instrument Article Number Stem Position Verification Tool Extended Compatibility These tools can only be used with specified stem implant systems. At the time of this manual revision, the Stem Position Verification Tools can be used with: DePuy AML Stems (Plus/ LG/ SM) Corail AMT Stems G2 Stems Proxima Stems Replica A Stems S-ROM Stems (11/13, 12/14, 9/10) Summit Stems Trilock BPS Stems Zimmer Alloclassic SL/SL HAC/ SLL/ SLO/ SLV, CLS stems (145, 135, 125 ) Smith & Nephew Anthology stems NOTE: Stem Position Verification Tools can also be used for verification of the DePuy 11/13 SROM, DePuy 12/14 Corail AMT, and Smith & Nephew integrated 12/14 trial implants. Only use a Stem Position Verification Tool with its specified stem implants. Instrument User Guide Rev. 1.1 Hip 81

82 Stem Position Verification Tools Stem Position Verification Tools Figure 50 No Component Stem Position Verification Tool Extended Black: for use with DePuy stem implants Exchangeable attachment Blue: for use with Zimmer stem implants Green: for use with Smith & Nephew stem implants Correct Use Use the Stem Position Verification Tools only for verification of stem position they are not designed to navigate stem placement. If the orientation of the Stem Position Verification Tool changes after a point has been acquired on the stem, verification of the stem s position is no longer valid, e.g., if the connection between the stem or the tracking array is altered in relation to the Stem Position Verification Tool. 82 Instrument User Guide Rev. 1.1 Hip

83 SURGICAL INSTRUMENTS 9.2 Offset Cup Impactor Universal (52856) Overview General Information Figure 51 The Offset Cup Impactor Universal enables navigated positioning of an acetabular cup implant through a small incision. Its offset design allows minimally-invasive transmission of impaction force directly to the acetabulum. The Offset Cup Impactor Universal comes with exchangeable threaded tips and nosepieces to adapt it for use with different types of cup implants. For more information check the interface compatibility on page 101. It has a stem mount for attachment of the StarLock Instrument Adapter to enable tracking of the instrument during computer-aided surgery. Instrument User Guide Rev. 1.1 Hip 83

84 Offset Cup Impactor Universal (52856) Components Figure 52 No Component Nose: Insertion point for implant specific nosepieces Release lever for tip driveshaft Notch for tip driveshaft alignment pins Tip driveshaft with ergonomic knob (blue) Ratchet Release lever for ratchet Mounting base for the StarLock Instrument Adapter Handle (blue) Nosepiece Threaded tip Locking nut Thread 84 Instrument User Guide Rev. 1.1 Hip

85 SURGICAL INSTRUMENTS Removing and Replacing the Impactor Nosepiece General Information The Offset Cup Impactor Universal nosepieces and threaded tips adapt the impactor for use with various implant types. Before using the impactor, attach the correct tip and nosepiece for the implant you intend to use. How to Remove and Replace the Nosepiece Steps To remove the nosepiece, gently pry it off the nose of the impactor. To replace the nosepiece press it onto the nose of the impactor until you hear a click. Instrument User Guide Rev. 1.1 Hip 85

86 Offset Cup Impactor Universal (52856) Changing the Threaded Tip General Use The exchangeable threaded tips of the Offset Cup Impactor Universal are designed for use with specific implants. Make sure that the implant-compatible threaded tip is attached to the impactor. Be certain to attach the correct threaded tip and nosepiece for the implant. Using an incompatible threaded tip or nosepiece may result in the implant not coming free of the impactor. Overview The procedure for changing the threaded tip entails the steps outlined in the table below and described in more detail on the following pages. Steps See Remove the nosepiece Page 85 Release the ratchet Page 86 Release the driveshaft Page 87 Change the threaded tip Page 87 Re-insert the tip into the impactor Page 87 How to Release the Ratchet Steps Figure Press the ratchet release lever and lift the tip driveshaft to free the ratchet from the shaft. 2. Slide the barrel of the ratchet toward the blue knob of the driveshaft until the ratchet is free and able to move freely up and down the driveshaft. 86 Instrument User Guide Rev. 1.1 Hip

87 SURGICAL INSTRUMENTS How to Release the Driveshaft 3 2 Figure 54 Steps While holding down the driveshaft release lever 2, pull the driveshaft back (toward the impactor handle) and upward to free the alignment pins from the notches 3. Lift the driveshaft upwards and bend it at its first joint (arrow) to disengage the tip from the nose and free the driveshaft from the impactor body. The tip should now hang free of the nose. How to Remove and Replace the Threaded Tip Figure 55 Steps 1. Unscrew the locking nut of the threaded tip. 2. Slide the old tip out of the driveshaft end joint. 3. Introduce the new tip into the driveshaft end joint. 4. Once the tip is fully inserted, tighten the locking nut finger-tight. How to Re-insert the Tip into the Impactor Steps 1. Bend the driveshaft at both joints and insert the tip into the impactor nose Straighten the driveshaft and press it down toward the shaft of the impactor until the locking pins click into place in the alignment notches. The tip should now project from the nose of the impactor. Attach the implant-specific nosepiece by pressing it onto the nose of the impactor until you hear it click in place. The impactor is now ready for you to affix the implant. Instrument User Guide Rev. 1.1 Hip 87

88 Offset Cup Impactor Universal (52856) Affixing and Locking the Implant on the Impactor How to Affix the Implant Some implants and their corresponding nosepiece tips have a squared or hexagonal interface. Make sure to correctly orient the interface of both components when introducing the nosepiece tip of the impactor into the implant. Do not overtighten. Overtightening can destroy the thread of the impactor tip and may make it difficult to release the implant. Steps 1. If the ratchet is not released, release the ratchet (see page 86). Introduce the impactor tip into the center (threaded) hole of the implant Screw the impactor tip into the implant by turning the blue knob on the end of the tip driveshaft clockwise. 4. With the implant on the impactor tip, re-introduce the ratchet into the matching hole. Press down gently on the driveshaft to engage the ratchet. You should hear three clicks. 5. After three clicks, the implant should still be free to rotate when the blue driveshaft knob is turned. 88 Instrument User Guide Rev. 1.1 Hip

89 SURGICAL INSTRUMENTS Steps Prior to Impaction Before Impaction The order of your next steps depends on the type of implant you are using. Options If you do not need to be able to turn the implant for alignment, your next steps are: Lock the implant down onto the impactor Attach the StarLock Instrument Adapter to the impactor Introduce the implant into the patient Perform impaction If you are using an implant with screw holes, and will need to be able to turn the implant to align it, your next steps are: Attach the StarLock Instrument Adapter to the impactor Introduce the implant into the patient and align the screw holes as needed by turning the blue knob clockwise Lock the implant down onto the impactor Perform impaction If you encounter any difficulties screwing the implant onto the impactor, continue the procedure using your standard impactor (non-navigation), and inform Brainlab immediately. Locking the Implant onto the Impactor Locking the implant down onto the impactor takes the pressure off the implant threads so that they are not stripped during impaction. Be sure to lock the implant to the impactor prior to impaction. If you fail to do so, the force of impaction may destroy the threads of the impactor or the implant, making it difficult or even impossible to remove the implant from the impactor. Step To lock the implant down onto the impactor, press the driveshaft firmly toward the impactor body until you can no longer rotate the implant by turning the blue knob. Once the implant is locked, you can perform impaction. Using the StarLock Instrument Adapter To enable computer-aided tracking of the impactor during surgery, you must attach the StarLock Instrument Adapter (see page 70). All reflective marker spheres on the StarLock Instrument Adapter must be visible to the camera while the instrument is being navigated. Before beginning navigation, make sure that the StarLock Instrument Adapter is correctly attached to the impactor and that the reflective marker spheres can be detected by both camera lenses. Instrument User Guide Rev. 1.1 Hip 89

90 Offset Cup Impactor Universal (52856) Releasing the Implant after Impaction How to Release the Implant Steps 1. Press the ratchet release lever. The ratchet mechanism releases. 2. Unscrew the impactor tip completely from the implant by turning the blue knob on the driveshaft counter-clockwise. 3. Pull the impactor out. 90 Instrument User Guide Rev. 1.1 Hip

91 SURGICAL INSTRUMENTS 9.3 Straight Cup Impactor Universal (52858) Overview General Information Figure 56 The Straight Cup Impactor Universal enables navigated positioning of a multiple acetabular cup implants through an incision. It allows minimally-invasive transmission of impaction force directly to the acetabulum. The Straight Cup Impactor Universal comes with exchangeable threaded tips and nosepieces to adapt it for use with different types of cup implants. For more information check the interface compatibility on page 101. It has a detachable mounting base to connect to the StarLock Instrument Adapter to enable tracking of the instrument during computer-aided surgery. Instrument Handling If the Straight Cup Impactor Universal has been damaged or dropped on the floor, it should no longer be used. Contact Brainlab immediately for advice on how to proceed. Instrument User Guide Rev. 1.1 Hip 91

92 Straight Cup Impactor Universal (52858) Components Figure 57 No Component Nose-insertion point for implant-specific nosepieces Handling nut (blue) Wingscrew Mounting base for the StarLock Instrument Adapter Handle (blue) Nosepiece Threaded tip Locking nut Thread 92 Instrument User Guide Rev. 1.1 Hip

93 SURGICAL INSTRUMENTS Assembling the Straight Cup Impactor How to Assemble the Straight Cup Impactor Steps 1. Release the handling nut completely by turning it counter-clockwise and sliding the driveshaft until the end is completely visible. 2. Introduce the implant-specific threaded tip into the driveshaft end joint. 3. Once the tip is fully inserted into the end joint, tighten the locking nut hand-tight to secure the tip. Instrument User Guide Rev. 1.1 Hip 93

94 Straight Cup Impactor Universal (52858) Steps 4. Screw the blue handling nut clockwise a few turns onto the thread. 5. Attach the implant-specific nosepiece by pressing it onto the impactor until you hear a click (symmetrical nosepieces only). 6. Position the mounting base for the Straight Cup Impactor Universal in the correct orientation and lock the wingscrew. 94 Instrument User Guide Rev. 1.1 Hip

95 SURGICAL INSTRUMENTS Adding and Removing the Impactor Nosepiece General Information The Straight Cup Impactor Universal nosepieces and threaded tips adapt the impactor for use with various implant types. Before using the impactor, attach the correct tip and nosepiece for the implant you intend to use. How to Add and Remove the Nosepiece Steps Attach the implant-specific nosepiece by pressing it onto the impactor until you hear a click (symmetrical nosepieces only). To remove the nosepiece, gently pry it off the nose of the impactor. Instrument User Guide Rev. 1.1 Hip 95

96 Straight Cup Impactor Universal (52858) Affixing and Locking the Implant on the Impactor (Symmetrical Nosepiece) How to Affix the Implant Some implants and their corresponding nosepiece tips have a squared or hexagonal interface. Make sure to correctly orient the interface of both components when introducing the nosepiece tip of the impactor into the implant. Do not overtighten. Overtightening can destroy the thread of the impactor tip and may make it difficult to release the implant. Steps 1. Ensure that the thread of the threaded tip is completely visible by adjusting the handling nut. 2. Insert the impactor tip into the center (threaded) hole of the implant. 3. With the implant on the impactor tip, lock the implant down by screwing the handling nut clockwise. 96 Instrument User Guide Rev. 1.1 Hip

97 SURGICAL INSTRUMENTS Affixing and Locking the Implant on the Impactor (Form Fit Nosepiece) How to Affix the Implant Some implants have a squared or hexagonal interface (see the interface compatibility list on page 101). When using those implants, fixation and locking the implant differs from the procedure listed above. Some implants and their corresponding nosepiece tips have a squared or hexagonal interface. Make sure to correctly orient the interface of both components when introducing the nosepiece tip of the impactor into the implant. Do not overtighten. Overtightening can destroy the thread of the impactor tip and may make it difficult to release the implant. Steps 1. Ensure that the thread of the threaded tip is completely visible by adjusting the handling nut. 2. Align the interface of the respective nosepiece into the implant. Then insert the impactor into the nose and the center (threaded) hole of the implant. Screw the implant onto the threaded tip by turning the handle. 3. With the implant on the impactor tip, lock the implant down by screwing the handling nut clockwise. Instrument User Guide Rev. 1.1 Hip 97

98 Straight Cup Impactor Universal (52858) Steps Prior to Impaction Before Impaction The order of your next steps depends on the type of implant you are using. Steps 1. Attach the StarLock Instrument Adapter to the mounting base of the impactor. 2. Insert the implant into the patient. 3. Align the screw holes of the implant as needed by turning the impactor accordingly. 4. If the StarLock Instrument Adapter is not visible to the cameras, slightly loosen the wingscrew, turn the mounting base with the Starlock Instrument to improve visibility, then tighten the wingscrew again. 5. Perform impaction. Lock the implant to the impactor prior to impaction. Otherwise the force of impaction may destroy the threads of the impactor or the implant, making it difficult or impossible to remove the implant from the impactor. If you encounter any difficulties screwing the implant onto the impactor, continue the procedure using your standard impactor (non-navigation), and inform Brainlab immediately. How to Release the Implant after Impaction Verify prior to impaction that the handling nut is completely tightened. If you do not lock the instrument, navigation accuracy decreases. Steps 1. Unlock the implant by screwing the handling nut counter-clockwise. 2. Unscrew the impactor tip completely from the implant by turning the inserter counterclockwise. 3. Pull out the impactor. 98 Instrument User Guide Rev. 1.1 Hip

99 SURGICAL INSTRUMENTS Using the StarLock Instrument Adapter To enable computer-aided tracking of the impactor during surgery, you must attach the StarLock Instrument Adapter (see page 70). All reflective marker spheres on the StarLock Instrument Adapter must be visible to the camera while the instrument is being navigated. Before beginning navigation, make sure that the StarLock Instrument Adapter is correctly attached to the impactor and that the reflective marker spheres can be detected by both camera lenses. Instrument User Guide Rev. 1.1 Hip 99

100 Straight Cup Impactor Universal (52858) Releasing the Implant after Impaction How to Release the Implant Steps 1. Press the ratchet release lever. The ratchet mechanism releases. 2. Unscrew the impactor tip completely from the implant by turning the blue knob on the driveshaft counter-clockwise. 3. Pull the impactor out. 100 Instrument User Guide Rev. 1.1 Hip

101 SURGICAL INSTRUMENTS 9.4 Insert For Universal Cup Impactor (52855) Overview General Information Figure 58 An Insert For Universal Cup Impactor is an exchangeable insert for use with Straight Cup Impactor Universal and Offset Cup Impactor Universal to be used with specific cups depending on the manufacturer. Interface Compatibility Medical Device/ Manufacturer Brainlab Article Number Thread/Nosepiece Aesculap: Plasmacup / M8X1/ Hexagonal Biomet: Mallory-Head Acetabular Shells USA Exceed Shells Universal Acetabular Shells USA Mallory-Head Acetabular Shells BiHAPro Shells BiomEX Shells Full Hemisphere Acetabular Shells USA / /4-28UNF/ Squared Corin: Trinity M10/Conical 13.5 mm Depuy: Duraloc Lagoon Pinnacle / /16-20UNF/ Conical12 mm Kyocera AMS: Instrument User Guide Rev. 1.1 Hip 101

102 Insert For Universal Cup Impactor (52855) Medical Device/ Manufacturer Brainlab Article Number Thread/Nosepiece / /8-24UNF/ Conical 12 mm Kyocera KMAX QPOC: / M8/ Conical 12 mm Mathys: selexys TPS selexys TH selexys PC selexys revision (TPS-R) / M10x1/ Conical 15 mm Smith & Nephew: Reflection Interfit R3 EP-FIT / /8-16UNC/ Hemispherical PPSU M6/Hemispherical PPSU Stryker: Trident Titanium / /8-24UNF/ Conical 12 mm Zimmer: Allofit Trilogy / /16-24UNF/ Hemisperical Ensuring Compatibility If you are using trial cups in combination with the standard cup impactor, use these trials to verify compatibility of the threaded tip and nose with the corresponding implant. Before using the impactor, you must attach the correct tip and nosepiece for the implant you intend to use. To ensure compatibility of threaded tips and nosepieces with new implants, contact Brainlab if you receive a new standard inserter (and new implants). 102 Instrument User Guide Rev. 1.1 Hip

103 SURGICAL INSTRUMENTS 9.5 Drill Guide (41839) Overview Use The Drill Guide is used for navigating drill bits and K-wires. Basic Components No. Component Comment Figure Drill guide tube Precalibrated tracking array Available in various diameters The diameter is engraved on the outer surface Enables instrument tracking 3 Fixation nut Secures the drill guide handle to the tracking array 4 Drill guide handle Can be rotated so that surgery is not obstructed and the tracking array remains visible to the camera throughout use. Drill Guide Tube Measurements Article Number 2.5 x 45 mm x 45 mm x 45 mm x 150 mm x 150 mm x 180 mm x 150 mm Instrument User Guide Rev. 1.1 Hip 103

104 Drill Guide (41839) Assembling the Drill Guide Before You Begin Use the appropriate tube for the intended application. For example, use a 3.0 mm tube for navigating 3 mm K-wires and a 3.2 mm tube for 3.2 mm drill bits. The diameter of the drill guide tube must match that of the drill bit or K-wire to be used. Otherwise navigation could be inaccurate, and the patient could be endangered. How to Assemble Figure 60 Steps 1. Insert tube 1 through the base of the tracking array without canting Screw the tube counterclockwise to tighten it. 3. Adjust handle to the most suitable angle, ensuring that the teeth of the handle interface lock correctly into place Secure handle using fixation nut Tightly screw reflective marker spheres by hand onto attachment pins of the tracking array. Precautions Tighten the tube securely, and do not, under any circumstances, loosen it during use. This would result in navigational inaccuracies. Once the handle has been adjusted to the required position, properly secure the fixation nut. 104 Instrument User Guide Rev. 1.1 Hip

105 SURGICAL INSTRUMENTS Navigation Drill Bits and K-wires The Drill Guide should only be used with drill bits and K-wires specified by Brainlab. Brainlab does not assume liability if other drill bits or K-wires are used. Ensure that the drill bits or K-wires are not bent. How to Navigate the Drill Guide Steps 1. Match Drill Guide angle and position to the planned trajectory shown on the screen. 2. Select a drill bit or K-wire with the same diameter as that of the tube selected. 3. To navigate a drill bit or K-wire of a different diameter, exchange the drill guide tube accordingly before continuing. To ensure accurate navigation of the planned axis, place the spikes of the drill guide tube directly on the bone surface. Do not change the orientation of the Drill Guide while drilling. This could cause the drill bit to fracture and break off in the bone. In the event of accuracy deviations with the navigated drill bit or drill guide tube, do not use the device. Validate it again or contact Brainlab for advice on how to proceed. Instrument User Guide Rev. 1.1 Hip 105

106 Drill Guide (41839) 106 Instrument User Guide Rev. 1.1 Hip

107 INDEX INDEX Numerics 1-Pin Wrench X-Press/ Spine Clamps A Adapter for Cup Inserter...19,72 attachment to cup inserter instrument compatibility B Bone Fixator "2-Pin", Flip-Flop, X-Press attaching Bone Fixator 1-Pin, Flip-Flop, X-Press, Size-S/M/L...18 Bone Fixator 2-Pin, Flip-Flop, X-Press Bone Fixators, X-Press Brainlab customer support...7 training...13 Brainlab Straight Cup Impactor Universal releasing implant... 90,100 C calibration ICM4 reference planes calibration accuracy validation cup impactors Cup Reamer Adapter... 19,75 attachment...76 Curved Cup Impactor Universal...83 customer support...7 D Disposable Clip-on Remote Control... 17,31 how to attach to pointer supported pointers...31 Disposable Reflective Marker Spheres attachment...22 sterility using Disposable Schanz Screws...17,24 sterility disposal instructions... 8 documentation...14 drill with fixation pins drill guide assembly Drill Guide...20 E Electromagnetic Environment... 38,39 Extended Pointer Sharp Tip F Femoral Broach Adapter DePuy attachment...79 fixation pins drilling Fixation Pins...16 Footswitch registration...42 Footswitch (USB) H Hip Caliper...19 I ICM overview reference planes...25 Insert For Cup Impactor Universal Insert For Universal Cup Impactor interface compatibility Instrument Adapter, StarLock Interface...19 instrument adapters...19 Instrument Calibration Matrix M Marker Spheres...21 attachment...22 sterility usability...22 Medical Device Directive... 8 MR Safety...15 O Offset Cup Impactor Universal changing threaded tips nosepieces P Pinless Femur Reference Array... 19,65 attachment to bone...66 Pointer Angled Extended Pointer Angled for Hip and Knee...17 pointer gauge Pointer Straight Extended pointers...17,27,29 accuracy ensuring accuracy handling...27 R Reference Array Kit, X-Press components Reference Array T-Geometry X-Press Reference Array Y-Geometry X-Press reference arrays reflective marker spheres Instrument User Guide Rev. 1.1 Hip 107

108 INDEX Reflective Marker Spheres attachment...22 using registration using the footswitch RF Emissions Interferences S Schanz screws... 17,24,48 sterility StarLock Adapter attachment...71 Correct Handling...71 StarLock Instrument Adapter...19 with curved cup impactor...83 with straight cup impactor universal Stem Position Verification Tool compatible implants...81 Extended Stem Position Verification Tool Extended...81 Stem Position Verification Tools sterilization Straight Cup Impactor Universal... 20,91 locking implant on impactor... 88,96,97 nosepieces sustainability...8 T training...13 U User Guides W WEEE...8 X X-Press Reference Array adjustment attaching Instrument User Guide Rev. 1.1 Hip

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